FDA 510(k) Applications Submitted by EWOO SOFT CO., LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190087 |
01/17/2019 |
EzDent-i / E2 / Prora View |
EWOO SOFT Co., Ltd. |
| K161117 |
04/20/2016 |
EzDent-i / E2 / Prora View |
EWOO SOFT CO., LTD. |
| K161246 |
05/03/2016 |
Ez3D-i / E3 |
EWOO SOFT CO., LTD. |
| K202116 |
07/30/2020 |
EzDent-i/ E2/ Prora View/ Smart M Viewer |
Ewoo soft Co., Ltd. |
| K172364 |
08/04/2017 |
EzDent-i / E2 / Prora View |
Ewoo Soft Co., Ltd. |
| K152746 |
09/23/2015 |
Ez3D Plus |
EWOO SOFT CO., LTD. |
| K173094 |
09/29/2017 |
OrthoVision |
Ewoo Soft Co., Ltd. |
| K202948 |
09/30/2020 |
EzOrtho |
Ewoo Soft Co., Ltd. |
| K192888 |
10/10/2019 |
EzOrtho |
Ewoo Soft Co., Ltd. |
| K163533 |
12/16/2016 |
EzDent-i; E2; ProraView |
EWOO SOFT CO., LTD. |
| K163539 |
12/16/2016 |
Ez3D-i / E3 |
EWOO SOFT Co., Ltd. |
| K173863 |
12/20/2017 |
Ez3D-i /E3 |
Ewoo Soft Co., Ltd. |
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